Image-guided therapy of a tissue

ABSTRACT

Image-guided therapy of a tissue can utilize magnetic resonance imaging (MRI) or another medical imaging device to guide an instrument within the tissue. A workstation can actuate movement of the instrument, and can actuate energy emission and/or cooling of the instrument to effect treatment to the tissue. The workstation and/or an operator of the workstation can be located outside a vicinity of an MRI device or other medical imaging device, and drive means for positioning the instrument can be located within the vicinity of the MRI device or the other medical imaging device. The instrument can be an MRI compatible laser or high-intensity focused ultrasound probe that provides thermal therapy to, e.g., a tissue in a brain of a patient.

RELATED APPLICATIONS

The present application is related to and claims the priority of U.S. Provisional Patent Application 61/955,121 entitled “Image-Guided Therapy of a Tissue” and filed Mar. 18, 2014. The present disclosure is also related to U.S. Provisional Patent Application 61/955,124 entitled “Image-Guided Therapy of a Tissue” and filed Mar. 18, 2014. The contents of each of the above listed applications are hereby incorporated by reference in their entireties.

BACKGROUND

Cancerous brain tumors can be “primary” tumors, meaning that the tumors originate in the brain. Primary tumors include brain tissue with mutated DNA that grows (sometimes aggressively) and displaces or replaces healthy brain tissue. Gliomas are one type of primary tumor that indicate cancer of the glial cells of the brain. While primary tumors can appear as single masses, they can often be quite large, irregularly-shaped, multi-lobed and/or infiltrated into surrounding brain tissue.

Primary tumors may not be diagnosed until the patient experiences symptoms, including those such as headaches, altered behavior, and sensory impairment. However, by the time the symptoms develop, the tumor may already be large and aggressive.

One treatment for cancerous brain tumors is surgery. Surgery involves a craniotomy (i.e., removal of a portion of the skull), dissection, and total or partial tumor resection. The objectives of surgery may include removing or lessening of the number of active malignant cells within the brain, or reducing a patient's pain or functional impairment due to the effect of the tumor on adjacent brain structures. Not only can surgery be invasive and accompanied by risks, for some tumors, surgery is often only partially effective. In other tumors, surgery may not be feasible. Surgery may risk impairment to the patient, may not be well-tolerated by the patient, and/or may involve significant costs, recovery time, and recovery efforts.

Another treatment for cancerous brain tumors is stereotactic radiosurgery (SRS). SRS is a treatment method by which multiple intersecting beams of radiation are directed at the tumor such that, at the point of intersection of the beams, a lethal dose of radiation is delivered, while tissue in the path of any single beam remains unharmed. However, confirmation that the tumor has been killed is often not possible for several months post-treatment. Furthermore, in situations where high doses of radiation may be required to kill a tumor, such as in the case of multiple or recurring tumors, it is common for the patient to reach a toxic threshold for radiation dose, prior to killing all of the tumors. Reaching this toxic threshold renders further radiation is inadvisable.

SUMMARY

A system or method for effecting treatment to a tissue, in some implementations, includes an automated drive mechanism with a holder to hold a treatment device (e.g., medical probe, ultrasonic applicator, laser fiber, etc.). In some implementations, the drive mechanism is motorless and consists of thermal imaging compatible components. The drive mechanism, for example, can be configured without an electric motor. The drive mechanism, in some examples, is included in an MRI or MRI head coil. The drive mechanism can be coupled to one or more wires or umbilicals such that a translation of the one or more wires or umbilicals affects one or more of a longitudinal displacement of the holder and a rotation of the holder. A controller, in some implementations, processes position control signals for setting and/or monitoring a position of the holder (e.g., via an input interface to the wires or umbilicals), and issues subsequent position control signals to manipulate positioning of the holder (e.g., via an output interface to the wires or umbilicals).

The system or method, in some implementations, includes a guide mechanism that is attachable to a surface of a patient. The guide mechanism, for example, can include a base structure configured to remain stationary relative to the patient when the guide mechanism is attached to the surface of the patient in a locked state. The guide mechanism can further include a tilt portion that is coupled to the base structure and provides an adjustable tilt between a trajectory of the drive mechanism and the base structure. The guide mechanism can further include a rotation portion that provides an adjustable rotation of the tilt portion relative to the base structure.

The controller, in some implementations, is configured to process a sequence of the position control signals to direct the guide mechanism to move the holder during treatment. For example, the controller can be programmed to move the holder to a first position for effecting the treatment to the tissue at a first portion of the tissue that coincides with the first position and then move the holder to a second position for effecting the treatment to the tissue at a second portion of the tissue that coincides with the second position.

During treatment, in some implementations, a workstation transmits the position control signals to the controller and displays feedback images (e.g., MRI images and/or thermometry images) of the tissue to an operator of the workstation. The workstation, for example, can continuously display the thermometry images of the tissue during the treatment to the tissue at the first and second portions of the tissue, and while the holder moves between the first and second positions.

In some implementations, an imaging system receives images of the tissue and the treatment device and analyzes the images to monitor control of positioning and/or therapeutic energy delivery within the tissue. For example, the imaging system may process, in real time, the images of the tissue and the treatment device and the thermometry images of the tissue to forecast errors or interruptions in the treatment to the tissue. Responsive to the analysis, the imaging system may display, via the workstation, a corresponding warning. Position control signals may be updated and transmitted by the workstation to the controller based on one or more of the images, as the images are received by the workstation in real time.

In some implementations, treatment is delivered via an energy emission probe, such as an ultrasonic applicator or laser probe. The energy emission probe, in some examples, may include one or more emitters, such as a radiofrequency emitter, a high-intensity focused ultrasound emitter, a microwave emitter, a cryogenic cooling device, and a photodynamic therapy light emitter. The energy emission probe may include multiple emitters, where the emitters are longitudinally spaced with respect to a longitudinal axis of the energy emission probe.

In some implementations, the energy emission of the probe can be controlled to generate a number of different output patterns. The different patterns, for example, can include energy delivered via two or more ultrasonic transducers and/or two or more laser fibers. For example, a laser probe may include a first laser fiber for outputting a symmetrical output pattern with respect to a longitudinal axis of the first laser fiber and a second laser fiber for outputting an asymmetrical output pattern with respect to a longitudinal axis of the second laser fiber. In another example, an ultrasonic applicator may include a first ultrasonic transducer for outputting a first ultrasonic frequency and a second ultrasonic transducer for outputting a second ultrasonic frequency.

The output pattern, in some implementations, includes a pulsed output pattern. For example, a higher power density may be achieved without causing tissue scorching by pulsing a high power laser treatment for x seconds with y seconds break between (e.g., for tissue in the immediate vicinity to cool down). In a particular example, the laser pattern may be active for two seconds and inactive for one second.

In some implementations, the treatment pattern includes effecting treatment while simultaneously moving the probe (e.g., linearly and/or rotationally). For example, an ultrasonic probe may be rotated while an emission pattern is simultaneously adjusted to effect treatment to a desired depth based upon a particular geometry of the region of interest (ROI). In this manner, for example, while the ultrasonic treatment beam is focused upon a radial portion of the tumor having a depth of 1.5 centimeters, the power density of the HIFU probe may be tuned for the first treatment depth. Upon rotation, a second radial portion of the tumor may have a depth of 2 centimeters, and the power density of the HIFU probe may be increased accordingly to tune for the treatment depth of 2 centimeters.

An energy source may be included to generate energy for the probe. In some implementations, the workstation transmits energy control signals to the energy source. The workstation, for example, may be configured to process a sequence of the energy control signals to first effect a symmetrical treatment to the tissue with the probe and then effect an asymmetrical treatment to the tissue with the probe after the symmetrical treatment. In a particular example, the workstation may be configured to process a sequence of position and laser control signals to move the holder to a first position for effecting the treatment to the tissue at a first portion of the tissue that coincides with the first position, effect a symmetrical treatment to the first portion of the tissue with the first laser fiber, move the holder to a second position for effecting the treatment to the tissue at a second portion of the tissue that coincides with the second position, and effect an asymmetrical treatment to the second portion of the tissue with the second laser fiber. During treatment, the workstation may be configured to display thermometry images of the tissue continuously throughout processing of the sequence of the position and energy control signals while effecting the symmetrical and asymmetrical treatments.

In some implementations, the system or method includes a guide sheath configured to accept two or more probes of different modalities as the treatment device. The modalities may include, for example, laser, radiofrequency, high-intensity focused ultrasound, microwave, cryogenic, photodynamic therapy, chemical release and drug release. The guide sheath may include one or more off-axis lumens (holes) for positioning an emitting point of one or more of the number of probes at an off-axis angle.

The system or method may include one or more processors and circuits that embody aspects of various functions by executing corresponding code, instructions and/or software stored on tangible memories or other storage products. A display may include various flat-panel displays, including liquid crystal displays.

In one aspect, the present disclosure relates to an apparatus including a low profile skull anchor device configured to attach to an area of a skull of a patient, the low profile skull anchor device including a central opening for access to an entry formed in the skull of the patient, where the low profile skull anchor device, upon attachment to the area of the skull, protrudes from the area of the skull at a height no greater than forty millimeters. The apparatus may further include a removable guide stem configured to detachably connect to the low profile skull anchor device, the removable guide stem including a cylindrical opening, where upon connection of the removable guide stem to the low profile skull anchor device, the cylindrical opening is positioned substantially above the entry formed in the skull of the patient, and the removable guide stem is configured to adjust a trajectory of the cylindrical opening in at least one of a tilt direction and a rotation direction.

In some implementations, the low profile skull anchor device includes at least three fastener positions for attaching the low profile skull anchor device to bone anchors set in the skull of the patient using screws. The low profile skull anchor device may include at least three skull pins for maintaining a gap between the low profile skull anchor device and a surface of the skull of the patient, thereby avoiding skin compression. The central opening of the low profile skull anchor device may be at least sixty millimeters in diameter.

In some implementations, the low profile skull anchor device includes at least two fastener openings for connecting the removable guide stem to the low profile skull anchor device. The removable guide stem may include a ball joint for adjusting the trajectory of the cylindrical opening in both the tilt direction and the rotation direction. The removable guide stem may include a tilt adjustment mechanism for adjusting the trajectory of the cylindrical opening in a tilt direction and a separate rotation adjustment mechanism for adjusting the trajectory of the cylindrical opening in a rotation direction. At least one of the removable guide stem and the low profile skull anchor device may include a number of guide lines for aid in setting the trajectory of the cylindrical opening.

In some implementations, the apparatus includes a guide sheath, where the guide sheath is configured for insertion within the cylindrical opening of the removable guide stem, and the guide sheath includes at least one hollow lumen extending between a proximal end of the guide sheath and a distal end of the guide sheath, where the at least one hollow lumen is configured for introduction of a neurosurgical instrument. The removable guide stem may include a lock mechanism for locking the guide sheath to the removable guide stem at a selected linear depth of insertion within the cylindrical opening of a number of linear depths of insertion available for selection. The distal end of the guide sheath may include two or more openings for deployment of the neurosurgical instrument.

In one aspect, the present disclosure relates to a head fixation system including an upper ring portion including a nose indent for positioning the nose of a patient when a head of the patient is encircled by the head fixation system, and a lower ring portion including a number of support posts, where the number of support posts are configured to support the head of the patient laid upon the lower ring portion, and the lower ring portion is configured to lock to the upper ring portion after positioning the head of the patient upon the number of support posts.

In some implementations, the support posts are adjustably connected to the lower ring portion via a number of slots, where the head fixation system includes more slots than support posts. Each support post of the number of support posts may include at least one connection point for connecting a fastener. The at least one connection point may be configured for connection of a skull pin. Each support post of the number of support posts may include at least three connection points for connecting a fastener, where a positioning of a fastener upon a first support post of the number of support posts is user selectable. Upon positioning the head of the patient between the lower ring portion and the upper ring portion and locking the lower ring portion to the upper ring portion, a user may tighten the fasteners to fix a position of the head of the patient.

In some implementations, the head fixation system includes one or more additional upper ring portions, where the upper ring portion is selected based upon a size of the head of the patient. The lower ring portion may be curved to provide at least forty degrees of angular head adjustment upon placing the head fixation system within a fixation ring channel of a patient table.

In one aspect, the present disclosure relates to a probe for use in effecting intracranial high intensity focused ultrasound (HIFU) treatment, including at least one ultrasonic transducer, an acoustic coupling medium contacting the at least one ultrasonic transducer, and a rigid external shaft for interstitial positioning of the at least one ultrasonic transducer, where the rigid shaft is up to 3.5 millimeters in diameter, and the at least one ultrasonic transducer is mounted within the rigid external shaft. The probe may be configured to drive ultrasonic energy at least three centimeters into tissue for effecting thermal treatment of the tissue.

In some implementations, the at least one ultrasonic transducer is mounted in a side-firing position within the rigid external shaft. The at least one ultrasonic transducer may include a linear array of three or more ultrasonic transducers. The at least one ultrasonic transducer may be a planar transducer. The thermal treatment may include one of coagulation and cavitation.

The foregoing general description of the illustrative implementations and the following detailed description thereof are merely example aspects of the teachings of this disclosure, and are not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of an exemplary layout of an MRI Control Room, an MRI Scan Room, and an MRI Equipment Room;

FIG. 2 is an illustration of a perspective view of a patient inserted into an MRI, with a head fixation and stabilization system installed;

FIG. 3 illustrates a probe driver;

FIGS. 4A and 4B are flow charts illustrating an exemplary procedure for treating a patient;

FIGS. 5A through 5E illustrate a low profile skull anchoring device and exemplary guide stems;

FIGS. 5F and 5G illustrate a guide stem and sheath configured to interconnect with the low profile skull anchoring device;

FIGS. 5H and 5I illustrate example internal configurations of a guide sheath;

FIG. 6 is a flow chart illustrating an example method for determining trajectory adjustments based upon initial position and orientation of probe introduction equipment upon the skull of a patient;

FIGS. 7A through 7C illustrate a high intensity focused ultrasound probe;

FIGS. 8A and 8B illustrate a method for MR thermal monitoring using offset thermal imaging planes; and

FIG. 9 illustrates exemplary hardware of a workstation.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

In the drawings, like reference numerals designate identical or corresponding parts throughout the several views.

As used herein, the words “a,” “an” and the like generally carry a meaning of “one or more,” unless stated otherwise. The term “plurality”, as used herein, is defined as two or more than two. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language). The term “program” or “computer program” or similar terms, as used herein, is defined as a sequence of instructions designed for execution on a computer system. A “program”, or “computer program”, may include a subroutine, a program module, a script, a function, a procedure, an object method, an object implementation, in an executable application, an applet, a servlet, a source code, an object code, a shared library/dynamic load library and/or other sequence of instructions designed for execution on a computer system.

Reference throughout this document to “one embodiment”, “certain embodiments”, “an embodiment”, “an implementation”, “an example” or similar terms means that a particular feature, structure, or characteristic described in connection with the example is included in at least one example of the present disclosure. Thus, the appearances of such phrases or in various places throughout this specification are not necessarily all referring to the same example. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more examples without limitation.

The term “or” as used herein is to be interpreted as an inclusive or meaning any one or any combination. Therefore, “A, B or C” means “any of the following: A; B; C; A and B; A and C; B and C; A, B and C”. An exception to this definition will occur only when a combination of elements, functions, steps or acts are in some way inherently mutually exclusive.

Further, in individual drawings figures, some components/features shown are drawn to scale to exemplify a particular implementation. For some drawings, components/features are drawn to scale across separate drawing figures. However, for other drawings, components/features are shown magnified with respect to one or more other drawings. Measurements and ranges described herein relate to example embodiments and identify a value or values within a range of 1%, 2%, 3%, 4%, 5%, or, preferably, 1.5% of the specified value(s) in various implementations.

The system or method may include one or more processors and circuits that embody aspects of various functions by executing corresponding code, instructions and/or software stored on tangible memories or other storage products. A display may include various flat-panel displays, including liquid crystal displays.

The treatment of tumors by heat is referred to as hyperthermia or thermal therapy. Above approximately 57° C., heat energy needs only to be applied for a short period of time since living tissue is almost immediately and irreparably damaged and killed, for example through a process called coagulation, necrosis, or ablation. Malignant tumors, because of their high vascularization and altered DNA, are more susceptible to heat-induced damage than healthy tissue. In other procedures, heat energy is applied to produce reversible cell damage. Temporary damage to cellular structures may cause the cells to be more conducive to certain therapies including, in some examples, radiation therapy and chemotherapy. Different types of energy sources, for example, laser, microwave, radiofrequency, electric, and ultrasound sources may be selected for heat treatment based on factors including: the type of tissue that is being treated, the region of the body in which the tissue to be treated is located, whether cellular death or reversible cellular damage is desired, the nature of energy application parameters for each source, and variability of the energy application parameters. Depending on these factors, the energy source may be extracorporeal (i.e., outside the body), extrastitial (i.e., outside the tumor), or interstitial (i.e., inside the tumor).

In interstitial thermal therapy (ITT), a tumor is heated and destroyed from within the tumor itself, energy may be applied directly to the tumor instead of requiring an indirect route through surrounding healthy tissue. In ITT, energy deposition can be extended throughout the entire tumor. The energy can be applied to heat tissue in the treatment area to a temperature within a range of about 45° to 60° C.

An exemplary ITT process begins by inserting an ultrasound applicator including one or more transducers into the tumor. The ultrasonic energy from the applicator may therefore extend into the tissue surrounding the end or tip including the one or more transducers to effect heating within the tumor. In some implementations, the transducer(s) is/are aligned with an edge of the applicator and the applicator is rotatable so as to rotate the ultrasonic energy beam around the axis of the applicator to effect heating of different parts of the tumor at positions around the applicator. In other implementations or for other applications, the transducer(s) are presented on a tip of the applicator or otherwise surrounding an inserted portion of the applicator. Depending upon the distribution of transducers, the applicator may be moved longitudinally and/or rotated to effect heating of the tumor over a full volume of the targeted region.

In yet other implementations, the ultrasonic applicator is controlled and manipulated by a surgeon with little or no guidance apart from the surgeon's memory of the anatomy of the patient and the location of the tumor. In still other implementations, images may be used during the ITT process to provide guidance for treatment. For example, locations of tumors and other lesions to be excised can be determined using a magnetic resonance imaging (MRI) system or computer tomography (CT) imaging system. During the ITT process, for example, MRI imaging can be used in real time to control or aid in guidance accuracy in an automated or semi-automated fashion.

In some implementations, thermography (e.g., MR thermography, ultrasonic thermography, etc.) provides contemporaneous temperature feedback regarding one or both of the targeted region and the surrounding tissue during the ITT process. The temperature information, for example, can be used to monitor necrosis of tumor tissue while ensuring that surrounding (healthy) tissue suffers minimal to no damage. The temperature feedback, in some implementations, is used to perform either or both of: automating engagement of the ultrasonic energy and cooling functionality of the ultrasonic applicator. In this manner, it is possible to control a temperature distribution or thermal dose in and around the tumor.

A system in accordance with this disclosure incorporates magnetic resonance imaging (MRI) compatible energy emission probes and/or other treatment devices and accessories for effective and controlled delivery of thermal therapy to a wide range of locations and tumor sizes within a brain. The system, however, is not limited to MRI-guided thermal therapy, as other therapies such as computer tomography (CT) can also be utilized. Further, this disclosure refers to an MRI scanner as an example medical imaging machine, which may be referred to simply as an MRI.

I. Overview

The interface platform 102 is secured to a patient table 108 of an MRI system 110. The MRI system 110 may include a head coil and stabilization system (herein stabilization system), an instrument adaptor, and an MRI trajectory wand. Exemplary MRI systems that can be utilized together with the features discussed herein include those manufactured by Siemens AG, Munich, Germany (including the MAGNETOM AVANTO, TRIO, ESPREE, VERIO MRI Systems, which are trademarks and/or trade names of Siemens AG). Further, example MRI systems include those manufactured by General Electric Company, Fairfield, Connecticut (including the SIGNA, OPTIMA and DISCOVERY MRI systems, which are trademarks and/or trade names of General Electric Company). In certain embodiments, all of the above components of the interface platform 102 and the energy emission therapy equipment are MRI compatible, which refers to a capability or limited capability of a component to be used in an MRI environment. For example, an MRI compatible component operates and does not significantly interfere with the accuracy of temperature feedback provided by the MRI system operating with exemplary flux densities including: magnetic flux densities of 1.5 T or 3.0 T, where no hazards are known for a specified environment (e.g., 1.5 T or 3.0 T). Compatibility can also be defined with respect to one or more other magnetic flux densities, including at least 0.5 T, 0.75 T, 1.0 T, 2 T, and 5 T.

In certain embodiments, the system electronics rack 104 includes cables, penetration panels and hardware that effectuates mechanical, electrical, and electronic operation of the energy emission therapy equipment and the MRI system 110. The system electronics rack 104 may further be used to power and route control signals and/or communications for the control workstation 106.

The workstation 106 includes a display that displays a user interface, e.g., a graphical user interface (GUI) and/or a command line interface that enables a user to plan a treatment procedure and interactively monitor the procedure, the interface platform 102, and the entire MRI system 110. In certain embodiments, the user interface also provides the user, e.g., a medical professional, the ability to directly control the energy emission therapy equipment including an energy source associated therewith, and therefore, enables directly control of the application of the therapy to the patient.

Turning to FIG. 2, an exemplary position of a patient on the patient table 108 of the MRI system 110 is illustrated. The interface platform 102 is secured to the patient table 108 together with a head coil 202 and stabilization system, which is a head fixation device that immobilizes a patient's head. The stabilization system includes a head fixation ring 204. A probe 206 and probe driver 208 are coupled to probe introduction equipment 210, and to the interface platform 102 via umbilicals. A cable, for example, can be used to provide data, laser, fluid, etc. connections between the probe 206, probe driver 208, and interface platform 102 and the electronics rack 104 in the MRI equipment room (as illustrated in FIG. 1).

The probe introduction equipment 210, in certain embodiments, includes at least a portion that is detectable by the MRI system (e.g., included in temperature data that is displayed by an imaging portion of the MRI system) and is used for trajectory determination, alignment, and guidance of the probe 206. An MRI trajectory wand (e.g., an MRI detectable, fluid-filled tube) may be placed into the probe introduction equipment 210, for example, to confirm a trajectory, associated with an intended alignment, to a targeted tissue region, via MRI. After confirmation, the probe 206 may be introduced into the probe introduction equipment 210 to effect surgery or therapy.

The probe 206 may be composed of MRI compatible materials that permit concurrent energy emission and thermal imaging, and can be provided in multiple lengths, cross-sectional areas, and dimensions. Types of probes that can be utilized with the components and procedures discussed herein include RF, HIFU, microwave, cryogenic, and chemical release probes; the chemical release probes may include photodynamic therapy (PDT), and drug releasing probes. Treatments in accordance with the descriptions provided in this disclosure include treatments that ablate (i.e., “treat”) a tissue to destroy, inhibit, and/or stop one or more or all biological functions of the tissue, or otherwise cause cell damage or cell death that is indicated by a structural change in cells of the targeted tissue area. Ablation can be effected by laser, RF, HIFU, microwave, cryogenic, PDT and drug or chemical release. A corresponding probe and/or other instrument, such as a needle, fiber or intravenous line can be utilized to deliver one or more of these ablation agents intracorporeally or percutaneously and proximate to, in the vicinity of, abutting, or adjacent to a targeted tissue area so as to effect treatment. The probe 206 can be a gas-cooled probe so as to control delivery of the energy to the targeted tissue area. The length and diameter of the probe 206 is preselectable based on the targeted tissue area and/or the ROI. The probe 206, in some particular examples, can be a laser delivery probe that is used to deliver laser interstitial thermal therapy or a HIFU applicator that is used to deliver HIFU interstitial thermal therapy.

The probe driver 208 controls positioning, stabilization and manipulation of the probe 206 within a specified degree of precision or granularity. Turning to FIG. 3, the components of the probe driver 208 generally include a commander 302, umbilicals 304, a follower 306, and a position feedback plug 308 that receives position feedback signals from, for example, potentiometers within the follower 306. The probe 206 (illustrated in FIG. 2) can be inserted into the follower 306, and the follower 306 can control a rotational and longitudinal alignment and/or movement of the probe 206. The probe driver 208 can further include a rotary test tool (not illustrated) that can be used during a self-test procedure to simulate attaching a probe to the follower 306. An exemplary probe driver that can be utilized in accordance with the various aspects presented in this disclosure is described in U.S. Pat. No. 8,728,092 to Qureshi, entitled “Stereotactic Drive System” and filed Aug. 13, 2009, the entirety of which is incorporated herein by reference.

The probe driver 208 (illustrated in FIG. 2) is mounted to the interface platform 102. The position feedback plug 308 (illustrated in FIG. 3) connects to the interface platform 102 in order to communicate the position of the probe 206 to the user and/or the workstation 106 (illustrated in FIG. 1). The probe driver 208 is used to rotate or translate, e.g., by extending or retracting the probe 206. The probe driver 208, in a particular example, can provide, at a minimum, a translation of 20-80 mm, 30-70 mm, 40-60 mm or 40 mm, with a maximum translation of 60 mm, 80 mm, 100 mm, 120 mm or 60-150 mm. The probe driver 208, further to the example, can also provide, at a minimum, a rotation of 300°-340°, with a maximum rotation of 350°, 359°, 360°, 540°, 720° or angles therebetween.

Returning to FIG. 1, in certain embodiments, the workstation 106 outputs signals, to the MRI system 110 to initiate certain imaging tasks. In other implementations, the workstation 106 outputs signals to an intermediary system or device that causes the MRI system 110 to initiate the imaging tasks. In certain embodiments, the workstation 106 additionally outputs signals to the electronics rack 104. The electronics rack 104 includes various actuators and controllers that control the thermal therapy devices, such as, in some examples, a cooling fluid pressure and/or a flow rate of the cooling fluid, and a power source that powers a thermal therapy device. In one example of a thermal therapy device, the power source is a laser source that outputs laser light via an optical fiber. As illustrated in FIG. 1, the electronics rack 104 is located in an MRI Equipment Room and includes storage tanks to hold the cooling fluid, one or more interfaces that receive the signals from the control workstation 106 and/or a separate MRI workstation, an energy emission source (e.g. laser), and an output interface. One or more of the interfaces are connected with or include physical wiring or cabling that receives the signals and transmits other signals, as well as physical wiring or cabling that transmit energy to corresponding components in the MRI Scan Room through a portal that routes the signals and/or energy in a manner that minimizes any interface with or by the MRI system 110. The wiring or cabling are connected at or by the interface platform 102 to corresponding components to effect and actuate control of a thermal therapy device and/or an associated thermal therapy session.

In certain embodiments, the system is indicated for use to ablate, necrotize, carbonize, and/or coagulate the targeted tissue area (e.g., an area of soft tissue) through interstitial irradiation or thermal therapy, in accordance with neurosurgical principles, with a HIFU thermal therapy device. The HIFU thermal therapy device or probe includes ultrasonic transducers for directing ultrasonic energy at the targeted tissue area, causing the tissue to heat. The ultrasonic beam of the HIFU probe can be geometrically focused (e.g., using a curved ultrasonic transducer or lens) or electronically focused (e.g., through adjustment of relative phases of the individual elements within an array of ultrasonic transducers). In an ultrasonic transducer array, the focused beam can be directed at particular locations, allowing treatment of multiple locations of an ROI without mechanical manipulation of the probe. The depth of treatment can be controlled by adjusting the power and/or frequency of the one or more transducers of the HIFU probe.

In certain embodiments, either additionally or alternatively to HIFU thermal therapy, a laser-based thermal therapy is utilized in the MRI system. Laser probes of a variety of outputs can be utilized, including, in some examples, laser probes emitting laser light having wavelengths of 0.1 nm to 1 mm, and laser probes emitting laser light in one or more of the ultraviolet, visible, near-infrared, mid-infrared, and far-infrared spectrums. Types of lasers used with respect the laser probe include, for example, gas lasers, chemical lasers, dye lasers, metal-vapor lasers, solid-state lasers, semiconductor lasers, and free electron lasers. In a particular example, one or more wavelengths of the laser light emitted by the laser probe are within the visible spectrum, and one or more wavelengths of the laser probe are within the near-infrared spectrum.

In certain embodiments, the environment 100 can be utilized for planning and monitoring thermal therapies effected via MRI-imaging, and can provide MRI-based trajectory planning for the stereotactic placement of an MRI compatible (conditional) probe. The environment 100, in certain embodiments provides real-time thermographic analysis of selected MRI images and thus, temperature feedback information and/or thermal dose profiles for the targeted tissue area. For example, thermographic analysis of the MRI images can provide real-time verification of cellular damage in a targeted tissue area that corresponds to necrosis, carbonization, ablation, and/or coagulation. In another example, thermographic analysis can be used to monitor tissue surrounding a periphery of an ROI to ensure minimal if any damage to healthy tissues. Components of the environment 100 may assist in guiding, planning, adjusting, performing and confirming a thermal therapy session and trajectories associated therewith.

A procedure includes, generally, identifying an ROI and/or associated targeted tissue areas in a patient that should be treated, planning one or more trajectories for treating the tissue, preparing the patient and components for the treatment, and performing the treatment. Aspects of the various parts of the treatment are described throughout this disclosure, and an exemplary sequence of treatment steps is illustrated in FIGS. 4A and 4B.

Turning to FIG. 4A, a process flow diagram illustrates an exemplary method 400 for pre-planning a treatment of a patient. In pre-planning the thermal therapy session, in certain embodiments, pre-treatment Digital Imaging and Communications in Medicine (DICOM) image data is loaded and co-registered, for example, via the workstation 106 (illustrated in FIG. 1). Using the DICOM image data, one or more ROIs and/or targeted tissue areas and one or more initial trajectories can be determined and set (402).

In preparation for treatment, in certain embodiments, a head coil and fixation system is attached to the patient (404), for example by positioning the head coil and stabilization system on the surgical table. The patient can be immobilized using a head fixation ring. To ensure stable imaging, for example, the patient's head can be secured with the head fixation ring and remain fixed for the entire imaging portion of the flow chart in FIG. 4A. An example head fixation system is described in U.S. Provisional Application Ser. No. 61/955,124 entitled “Image-Guided Therapy of a Tissue” and filed Mar. 18, 2014.

Prior to applying thermal energy to an ROI, a probe entry location into the skull is identified. In certain embodiments, a burr hole is drilled in the skull (406). The burr hole may be drilled prior to attachment of probe introduction equipment (e.g., a miniframe, anchoring device, guide stem, instrument sheath, etc.). A twist-drill hole, in certain embodiments, can be created following a trajectory alignment of the probe introduction equipment. The twist-drill hole can have a size of 1-5 mm, 2 mm, 3 mm, 4 mm or 4.5 mm.

The probe introduction equipment, such as a stereotactic miniframe or low profile anchoring device, in certain embodiments, is attached to the patient's head (408). Probe aligning equipment, such as the miniframe or guide stem, can then be aligned along the intended trajectory, for example using image-guided navigation. After attaching the probe introduction equipment, the head coil can be attached. An exemplary head coil system is described in U.S. Provisional Application Ser. No. 61/955,124 entitled “Image-Guided Therapy of a Tissue” and filed Mar. 18, 2014. Depending on a process flow that is specific to a surgical center, the interface platform may be attached prior to or after MRI trajectory confirmation. The order of steps in a site-specific process may be determined based on members of MRI or surgical support team and may be determined during on-site training with respect to the MRI system. The interface platform (IP) is attached to the head end of the head coil and stabilization system. Then, the IP power and motor plugs are connected.

In certain embodiments, the patient is positioned in a MRI cabin, and MRI imaging is performed to confirm a trajectory (410) associated with a thermal therapy device and/or probe introduction equipment. For example, an MRI trajectory wand may be inserted into the probe introduction equipment for use in confirming its trajectory. The trajectory of the probe introduction equipment, for example, can be evaluated using MRI imaging prior to inserting a probe into the brain. Volumetric imaging or volumetric visualization may be captured to include the entire head and full extent of the probe introduction equipment, independently of ablation. Along with trajectory confirmation, in some examples, beam fiducial marker detection may also be performed. For example, the captured images may also display a position of a beam fiducial marker located in a portion of the probe introduction equipment. This marker can be detected and identified by the MRI imaging system and method to store an orientation of the physical direction of the probe. The captured images, in implementations where pre-treatment image data is not available, can be used for planning a thermal therapy session.

In certain embodiments, a probe actuation and guidance device (e.g., a follower) and a test tool are attached to the probe introduction equipment, to provide positional feedback for a self-test function (412). The self-test function, for example, may be used to confirm that inputs to the probe actuation and guidance device, (e.g., from the workstation), accurately and/or precisely drive the probe. Upon completing the self-test function, the rotary test tool may be removed. Upon completing the procedure described in relation to FIG. 4A, the procedure equipment may be introduced and the procedure initiated.

Turning to FIG. 4B, a process flow diagram illustrates an exemplary method 420 for a treatment procedure. In certain embodiments, a probe is attached and inserted into the probe introduction equipment and/or the patient's skull (e.g., secured for manipulation via the probe actuation and guidance device) (422). Exemplary implementations of neurosurgical probes are discussed in below under the section entitled “Probes.” It is noted that different types of probes can be used in conjunction different types of thermal therapy, for example, when an ROI is not in the brain. An MRI scan can then be conducted to ensure probe alignment is correct and confirm movement and delivery of the probe along the intended trajectory. In one example, the acquired image data can be displayed, along with pre-planning image data by the workstation 106. Using a graphical user interface (GUI), a user can adjust the probe displayed by the GUI by interacting with, for example, the GUI to match the probe artifact on the acquired image to ensure that the alignment and arrangement of the probe as physically placed in the probe introduction equipment and inserted into the patient coincides with the rendered probe at the workstation. The probe's trajectory, for example, can be adjusted to a desired position for delivering thermal energy, via interaction with the GUI. Further, the probe's rotational position can also be adjusted to a desired direction or angle for thermal delivery, via interaction with the GUI. Once the probe rendering presented by the GUI matches the probe artifact on the display, the user may confirm the trajectory via the GUI.

In certain embodiments, one or more scan planes are selected for cuing a thermal monitoring sequence via the MRI system's sequence protocol list (424). In another embodiment, a 3D volume is selected and in yet another embodiment, a linear contour is selected. Parameters associated with scan plane, in some examples, can be entered by a user via a workstation connected with the MRI system or directly into the thermal monitoring sequences protocol's geometry parameters of the MRI.

In certain embodiments, temperature feedback information and/or thermal dose profiles are initialized and monitored (426). For example, under a noise masking heading of the workstation interface, at least three reference points (e.g., six, twelve, twenty, etc.) can be selected by the user at the periphery of the ROI. The ROI, for example, may include an overlaid, orange noise mask in one or more image monitoring view panes to illustrate the intended thermal delivery area. The noise masking may be used to improve accuracy of temperature monitoring during tissue treatment.

In certain embodiments, energy delivery via the probe is actuated to begin the thermal therapy session (428). For example, once “Ready” indicator or the like is displayed under a laser status heading of the GUI at the workstation, the user may depress a foot pedal operatively connected to the workstation to deliver thermal energy to the ROI or a targeted tissue area within the ROI. Thermal energy can then be either continuously or intermittently delivered while monitoring thermal dose profiles, which can be presented as contours that are overlaid onto one or more (e.g., three) thermal monitoring view panes rendered by the GUI of the work station. Thermal delivery may be halted as desired or as necessary by releasing the foot pedal. The view panes, for example, may display an energy dose profile or thermal dose profile supplied by the probe, with respect to a specified time period and/or a specified targeted tissue area or ROI; the thermal dose or energy dose profile can be displayed as a succession of temperature gradients. The thermal dose profiles and/or the temperature gradients permit the determination of an extent of cellular damage in the targeted tissue area and/or other effects upon the targeted tissue area occurring as a result of the thermal therapy.

Once a thermal dose for a particular alignment and positioning of the probe is completed, if further probe alignments are desired within the treatment plan (430), a rotational and/or linear alignment of the probe may be adjusted (432) by translating or rotating the probe. For example, an energy output of the probe may be terminated and then the probe may be subjected to linear translation and/or rotational movement, which can be controlled, for example, by a probe driver (a particular implementation of which is illustrated in FIG. 3). After adjusting the probe alignment, in certain embodiments, the process returns to step 422 to verify a current placement of the probe. In certain embodiments, a second thermal treatment procedure is not initiated (e.g., when repeating step 428) until one or more targeted tissue areas within the ROI returns to a baseline body temperature. The thermal dose associated with the one or more targeted tissue areas in the ROI, as described in relation to steps 422 through 432, may continue at various probe rotational and/or linear alignments until the entire ROI has been treated.

Upon determining that the thermal therapy is complete (430), should treatment with an additional probe be needed or desired (434), the procedure can be repeated by attaching the new probe to the probe introduction equipment and verifying probe placement (422). If, instead, the second probe was initially included within the probe introduction equipment (e.g., via a separate lumen in a guide sheath in relation to the first probe), the user may initiate positioning of the second probe, for example, via the GUI, and verify placement of the second probe (422). A multi-probe configuration is described in greater detail in relation to FIG. 5I.

If the second probe is being deployed to treat the same ROI or the same targeted tissue area at the same linear and rotational alignment(s) associated with the first probe, in certain embodiments, step 424 involving selection of scan planes for the cuing the thermal monitoring sequence may be skipped. If, instead, a second probe is deployed at a different linear position or a different trajectory, step 422 may be performed to confirm the trajectory and alignment of the second probe.

When the thermal therapy is complete (434), in certain embodiments, the patient is removed from the MRI bore and the probe, probe actuation and guidance device, and probe introduction equipment are detached from the patient. The bore hole may be closed, for example, at this time.

II. Low Profile Probe Introduction Equipment

A. Low Profile Skull Anchoring Device

In certain embodiments, when preparing for an intracranial neurosurgical procedure, a patient 502 is fitted with a low profile skull anchoring device 504, as illustrated in an exemplary mounting illustration 500 of FIG. 5A. The low profile skull anchoring device 504 may be releasably attached to the head of the patient 502, for example, using three or more bone anchors mounted to the skull of the patient 502. Turning to FIG. 5B, the low profile skull anchoring device 504 includes three bone screws 508 for connecting to bone anchors within the skull of the patient 502, as well as pins 510 for further securing the low profile skull anchoring device 504 to the head of the patient 502 and for ensuring that the low profile skull anchoring device 504 mounts above the surface of the head of the patient 502. In this way, there will be minimal or no compression of the patient's scalp. In one embodiment, the low profile skull anchoring device 504 has an oval or an oblong shape.

In one embodiment, the screws 508 and pins 510 are composed of, for example, titanium. It should be noted that the screws 508 and the pins 510 are not necessarily limited to three pins; the number of screws 508 and pins 510 used is the number which is necessary to provide sufficient rigidity. The screws 508 and pins 510 may be evenly spaced around the circumference of the low profile skull anchoring device 504 (e.g., positioned approximately every 120 degrees). In another embodiment, the screws 508 and pins 510 are positioned at unequal distances apart, for example, based on an irregular skull curvature. In yet another embodiment, the screws 508 and the pins 510 are movable with respect to the low profile skull anchoring device 504. In still another embodiment, the screws 508 are replaced with a sufficiently rigid adhesive or a staple, each of which provide sufficient rigidity to allow for the drilling of a burr hole in the skull.

Due to the low height of the low profile skull anchoring device 504, the medical team is provided with greater access for lateral trajectories of biopsy, probes, and other apparatus to be inserted intracranially into the patient 502 via the low profile skull anchoring device 504. This may be especially useful when working within the confines of an MRI bore, for example during MRI-guided thermal therapy treatments. As such, the low profile skull anchoring device 504 may be composed of MRI compatible materials and, optionally, include MRI visible markers for aligning a desired trajectory or defining a particular direction relative to the low profile skull anchoring device 504. In another example, the low profile skull anchoring device 504 may allow easier access to back-of-the-head entry trajectories, such as trajectories used in performing epilepsy treatments. A mounting height of the low profile skull anchoring device 504, for example, may be thirty millimeters or less from the surface of the skull of the patient 502.

B. Removable Guide Stem

Turning to FIG. 5A, the low profile skull anchoring device 504 includes a removable guide stem 506. The removable guide stem 506, in some examples, may lock to the low profile skull anchoring device 504 using a screw mechanism, keyed locking mechanism, or other connector configured to firmly connect the removable guide stem 502 to the low profile skull anchoring device 504 with relative ease of removal.

Turning to FIG. 5B, the exemplary the low profile skull anchoring device 504 includes three connection points 512 for securing the removable guide stem 506 to the low profile skull anchoring device 504. The removable guide stem 506, for example, may include a series of guide stem connectors 514 (e.g., screws or locking pins) which mate with the connection points 512 of the low profile skull anchoring device 504, as shown in FIGS. 5A and 5C. In one embodiment, the alignment of the guide stem connectors 514 and the connection points 512 differs based on a skull curvature of the patient.

In another example, the removable guide stem 506 may lock to the low profile skull anchoring device 504 using a keyed mechanism, such as an insert-and-twist slot and tab configuration (not illustrated). In still further examples, the removable guide stem 506 may releasably connect to the low profile skull anchoring device 504 using retractable locking pins which mate to corresponding depressions. For example, retractable pins built into the low profile skull anchoring device 504 may be extended to mate with corresponding depressions within the removable guide stem 506. In another example, spring-loaded retractable locking pins may be pressure-inserted into mating depressions within the removable guide stem 506, for example by pushing the removable guide stem 506 into the interior diameter of the low profile skull anchoring device 502. Further to this example, a latch or button mechanism may be used to retract the locking pins and release the removable guide stem 506 from the low profile skull anchoring device 502. Other locking mechanisms are possible.

A central cylindrical portion of the removable guide stem 506 is configured to receive various adapters and/or instruments such as, in some examples, drill bits, biopsy needles, and treatment probes. The central cylindrical portion of the removable guide stem 506, in certain embodiments, is rotatably adjustable, allowing an orientation of central cylindrical portion of the removable guide stem 506 to be manipulated to align the probe in accordance with a desired trajectory. Upon alignment, in certain embodiments, a locking mechanism 516 may be actuated to lock the central cylindrical portion of removable guide stem 506 into place at the set alignment.

Turning to FIG. 5C, the removable guide stem 506 may include, for example, a ball joint 518 for establishing an adjustable trajectory for passing instruments to the skull of the patient 502 via the central cylindrical portion of removable guide stem 506. In certain embodiments, the central portion has another geometric or polygonal shape that corresponds to a cross-section of the probe. In certain embodiments, interior portions of the central cylindrical portion of the removable guide stem 506 are deformable so as to cover an outer surface of the probe. In still other embodiments, the interior portions of the central cylindrical guide stem are comprised of shape memory alloys that have a transition temperature that exceeds a maximum temperature associated with a specified thermal therapy.

The ball joint 518 can achieve a number of trajectories that is based on the granularity with which the ball joint 518 is manipulated. Upon setting the trajectory of the central cylindrical portion of removable guide stem 506, for example, the ball joint 518 may be clamped into position using the locking mechanism 516. In one embodiment, the locking mechanism 516 is a cam lock. In another embodiment, the locking mechanism 516 is a ring clamp. In still another embodiment, the locking mechanism 516 has a screw engagement. In another example, the ball joint 518, upon positioning of the trajectory, may be clamped into position using a ring clamp (not illustrated).

In some implementations, the ball joint may be perforated and/or indented at set increments such that, rather than an infinitely adjustable trajectory, the removable guide stem 506 has a multiple selection trajectory allowing for precise adjustment. Upon positioning, for example, a screw engagement or locking pin may lock the ball joint 518 at the selected position. Further to the example, to aid in precision adjustment, guide lines or trajectory markers may indicate a selected trajectory (e.g., in relation to a plane of the low profile skull anchoring device 504).

Turning to FIGS. 5D and 5E, illustrative examples of a removable guide stem 520 including both a tilt adjustment 522 and a rotation adjustment 524 are shown. The separate tilt adjustment 522 and rotation adjustment 524, for example, may be used to more precisely adjust a trajectory of the central cylindrical portion of removable guide stem 520. Upon adjusting the tilt adjustment 522, for example, a tilt lock mechanism 526, such as a screw and hole or locking pin and pin slot, may be activated to hold the central cylindrical portion of removable guide stem 520 at the selected tilt position. In another example, upon adjusting the rotation of the central cylindrical portion of removable guide stem 520, for example by turning the rotation adjustment 524, a rotation lock mechanism 528, such as a screw and hole or locking pin and pin slot, may be activated to hold the removable guide stem 520 at the selected rotation.

In other implementations, the tilt adjustment 522 and/or rotation adjustment 524 includes a graduated friction lock, such that asserting pressure along the line of adjustment causes the trajectory to “click” to a next incremental setting (e.g., one, two, or five degrees). In this circumstance, a user can count a number of clicks to determine a present relative trajectory selected. In one embodiment, the graduated friction lock includes a rack and pinion mechanism. In another embodiment, the graduated friction lock includes detents and a spring-loaded plunger.

In certain embodiments, guide lines such as a set of guide lines 530 are marked on the removable guide stem 520 (or the removable guide stem 506 illustrated in FIG. 5A) to provide a user with an indication of the selected trajectory. For example, an angle of tilt in relation to the low profile skull anchor 504 may be selected via the guide lines 530 (e.g., within a one, two, or five degree angle of adjustment). The guide lines 530, in certain embodiments, are MR indicators, such that an MR image captured of the removable guide stem 520 will allow a software package to register an initial trajectory in relation to the head of the patient (e.g., patient 502 of FIG. 5A).

In certain embodiments, in addition to a tilt and rotation adjustment, either the first removable guide stem 506 or the second removable guide stem 520 may be modified to include an x,y degree of freedom adjustment mechanism (not illustrated). In this manner, a position of the central cylindrical portion of guide stem 506 in relation to a burr hole opening beneath the low profile skull anchor 504 may be adjusted by the user. Rather than the central cylindrical portion of guide stem 506 or 520 being centered within the low profile skull anchor 504, for example, an x,y adjustment mechanism may allow an offset of the central cylindrical portion of removable guide stem 506 or 520. In a particular example, should the burr hole fail to be centered between bone anchors planted within the skull of the patient 502, the central cylindrical portion of guide stem 506 or 520 may be adjusted by up to at least ten to twenty millimeters to be centered above the burr hole using an x,y adjustment mechanism.

For example, the x,y adjustment mechanism may be configured using an adjustable spring loaded cam and locking mechanism (e.g., set pin or screw). In another example, the x,y adjustment mechanism may be configured using an adjustable hinge configuration, such that the legs of the “Y” shape of the guide stem 506 are capable of swinging along an adjustment travel of the hinge configuration.

In some implementations, the guide stem 506, rather than being fixedly connected to the low profile skull anchor 504, may be adjustably connected to the low profile skull anchor 504. For example, the guide stem 506 may connect to an adjustable gantry system, such that the x,y displacement of the guide stem 506 can be set through an adjustable gantry. In a further example, the x, y adjustment mechanism can be configured using a rotatable ring configured between the low profile skull anchor 504 and the guide stem 506, such that the Y shape of the guide stem 506 may be twisted to a desired trajectory and then the guide stem 506 may be adjusted closer to the low profile skull anchor 504 along an adjustment leg of the Y shape. For example, an adjustment mechanism may be provided along a particular leg of the Y shape such that, to implement x,y adjustment, the Y is first rotated into a desired position, and then linear travel effected along the adjustment branch of the Y.

In some implementations, rather than a Y-shaped removable guide stem mechanism such as guide stem mechanism 506, the removable guide stem mechanism includes an X-shaped connection to aid in x,y adjustment. In this configuration, the x,y adjustment mechanism can include a slideable gantry with locking mechanisms such as a clamp or set screw. In another example, the x,y adjustment may include a screw drive, allowing a user to twist and adjust the displacement of the central position of the guide stem 506 in either or both the x direction and the y direction. Further, the spring-loaded cam and/or hinge system adjustment mechanisms described above in relation to the Y-shaped configuration are equally applicable to an X-shaped configuration.

Turning to FIG. 5B, upon removal of the removable guide stem 506 or 520, the skull entry location becomes accessible, for example to allow for formation of a burr hole or to otherwise prepare the skull entry location. After preparation of the entrance, the removable guide stem 506 or 520 may be locked to the low profile skull anchor 504. For example, as illustrated in FIG. 5D, the removable guide stem 520 may be locked to the low profile skull anchor device 504 by attaching screws at three connection locations 532. In another example, the removable guide stem 520 may be clamped to the low profile skull anchor device 504. At any point in a procedure, should access to the entrance be desired, the guide stem 520 may be removed. Removal of the guide stem 520, for example, allows a medical professional quick access to react to bleeding or to adjust the burr hole opening for trajectory correction.

When performing a medical procedure via the low profile skull anchoring device 504, in certain embodiments, the low profile skull anchoring device 504 may first be aligned with screw anchors mounted upon the patient's skull and then screwed to the head of the patient 502, as illustrated in FIG. 5A. The skull entry location may be prepared for treatment during the thermal therapy while the removable guide stem 506 or 520 has been separated from the low profile skull anchoring device 504. Following preparation of the skull entry location, the removable guide stem 506 or 520 may be replaced and its trajectory aligned.

To align the removable guide stem 506, 520 with a desired treatment trajectory, in certain embodiments, the removable guide stem 506, 520 is automatically manipulated. For example, the removable guide stem manipulation may be performed by software executing upon the commander 302 of the probe driver 208 as described in relation to FIG. 3. In another example, the removable guide stem 506 may be manipulated via a trajectory planning module of a software system, such as software executing upon the workstation 106 of FIG. 1.

The manipulations of the removable guide stem 506, 520, for example, may be performed by a probe actuation and guidance device. In a particular example, as described in relation to the method 400 of FIG. 4A, a test tool may be inserted into the removable guide stem 506, 520, and the test tool may be aligned with pre-treatment image data to determine an initial trajectory. In another example, automatic manipulation may be supplemented with real time images supplied by an image guided system (e.g., MRI-imaging system). For example, the test tool alignment may be monitored and verified by a software algorithm through capture of MRI images during manipulation. In other implementations, an operator manually adjusts the trajectory of the removable guide stem 506, 520. Alignment of the trajectory of the removable guide stem 506, 520, in some implementations, is aided by one or more guide lines or fiducial markers upon the surface of the low profile skull anchoring device 504 and/or upon the surface of the removable guide stem 506, 520, such as the guide lines 530 illustrated in FIG. 5D.

Upon positioning the trajectory of the removable guide stem 506, 520, in certain embodiments, the trajectory is locked via a locking mechanism, such as the locking mechanism 516 of FIG. 5C or the locking mechanisms 526 and 528 of FIG. 5D.

After the removable guide stem 502 has been locked into its initial trajectory, in certain embodiments, instruments may be guided into the skull via the removable guide stem 506 or 520. For example, biopsy tools, a thermal treatment probe, medicament delivery probe, or other neurosurgical device may be delivered to a ROI of the brain of the patient via the removable guide stem 506 or 520.

C. Trajectory Positioning

FIG. 6 is a flow chart illustrating an example method 600 for determining trajectory adjustments based upon initial position and orientation of probe introduction equipment upon the skull of a patient. The method 600, for example, may be used in determining a trajectory prior to conducting a neurosurgical procedure. In some implementations, the method 600 is performed by software executing upon the workstation 106, as described in relation to FIG. 1. In another example, the method 600 is performed by software executing upon the commander 302 of the probe driver 208 as described in relation to FIG. 3.

In some implementations, the method 600 begins with obtaining an MRI image of a skull of a patient fitted with probe introduction equipment (602). The MRI image, for example, may be obtained by the MRI system 110, as described in relation to FIG. 1. MRI image data including two or more images, in other examples, may be obtained from a remote medical system, for example through a hospital file transfer system. Further, MRI image data, in some implementations, may be scanned into the system and loaded into the software.

In some implementations, one or more fiducial markers identifying probe introduction equipment are determined from the MRI image (604). For example, a software system installed upon the workstation 106 can review the MRI image data for graphical data matching a known fiducial marker related to probe introduction equipment. For example, a particular shape or series of shapes may be indicative of the location of probe introduction equipment, such as the low profile skull anchoring device 504 described in relation to FIGS. 5A through 5E or the stereotactic miniframe described in U.S. patent application Ser. No. 13/838,310 to Tyc, entitled Image-Guided Therapy of a Tissue and filed Mar. 15, 2013, which is hereby incorporated by reference in its entirety.

In some implementations, if a type of the probe introduction equipment is unknown (606), a type of the probe introduction equipment may be determined based upon one or more of the shapes, sizes, lengths, and/or positions of the identified fiducial marker(s) (608). For example, based upon a particular arrangement or shape of fiducial marker, the software algorithm may differentiate the low profile skull anchoring device from the stereotactic miniframe. In another example, a particular arrangement of fiducial markers may be used to differentiate a low profile skull anchoring device with an x,y adjustment guide stem from a low profile skull anchoring device with an immobile guide stem.

In other implementations, the type of probe introduction equipment may be known (606). For example, the software may be bundled with particular probe introduction equipment such that the fiducial markers are only used to identify positioning of the known probe introduction equipment. In another example, a user may manually enter the type of probe introduction equipment into the software (e.g., through a drop-down selection menu or other selection mechanism). In a further example, a communication may be received from the probe introduction equipment by the software, identifying the type or model of probe introduction equipment. In a particular illustration of this example, an algorithm executing upon the commander 302 of the probe driver 208 (illustrated in FIG. 3) communicates information regarding the type of probe introduction equipment to the software.

Once the type of probe introduction equipment has been identified, in some implementations, a position and orientation of the probe introduction equipment is determined using the identified fiducial markers (610). For example, based upon a particular distribution of fiducial markers, the software may identify the mounting location of the probe introduction equipment in relation to the skull of the patient. Fiducial markers, as a particular illustration, may identify the relative locations of the bone screws 508 of the low profile skull anchoring device 504, as illustrated in FIG. 5B. In another example, the trajectory of the guide stem 506, as illustrated in 5C, may be determined based upon an angle of a fiducial marker line or shape upon the guide stem 506.

The position and orientation of the probe introduction equipment, in some implementations, is determined with reference to the skull of the patient. For example, identifying relative locations of the bone screws 508 based upon fiducial markers upon the low profile skull anchor 504 may identify position of the head of the patient. In another example, fiducial marker stickers may be applied to the head of the patient to identify the head relative to the probe introduction equipment. Features of the head of the patient, such as brow, ears, nose, or cheek bones, for example, may be highlighted to orient the position of the low profile introduction equipment in relation to the face of the patient.

In other implementations, position and orientation of the probe introduction equipment is determined relative to imaging or head stabilization equipment. In a first example, the position and orientation of the probe introduction equipment may be determined based upon one or more fiducial marker reference points on the head coil 202 or the head fixation ring 204, as illustrated in FIG. 2.

In some implementations, a position of a portion of the probe introduction equipment may be identified in relation to other probe introduction equipment. For example, as described in relation to the guide stems 506 and 520 of FIGS. 5A through 5E, an x,y degree of freedom adjustment mechanism may have been used to modify the position of the central cylindrical portion of guide stem in relation to a burr hole opening beneath the probe introduction equipment. If the central cylindrical portion of the guide stem is offset in relation to the low profile skull anchoring device 504, for example, the software may calculate the position of the offset.

In some implementations, a representation of the probe introduction equipment is overlaid on the displayed MRI image (612). For example, based upon the type, position, and orientation determined above, the software may overlay a reference image (e.g., semi-transparent image, dotted outline, etc.) representing the location of at least a portion of the probe introduction equipment. For example, a position and orientation of the guide stem 506 attached to the low profile anchoring device 504 (e.g., as illustrated in FIGS. 5A and 5C) may be presented to the user. The overlaid image, in some embodiments, mimics the look and design of the actual probe introduction equipment. In other embodiments, the overlaid image is a simple dotted line orientation image that may bear little similarity to the look of the actual equipment.

In some implementations, a target region of interest in the skull of the patient is determined (614). For example, as described in step 402 of the method 400, discussed with reference to FIG. 4A, pre-treatment image data may be used to identify one or more treatment regions of interest. In one example, a user may manually identify a region of interest, for example by highlighting or circling the region of interest within the MRI image. The region of interest, for example, may include a tumor or portion of a tumor. In some implementations, the region of interest is identified as a three-dimensional location within the skull of the patient. For example, the region of interest may identify a target point for a tip of a probe to reach. In other implementations, the region of interest may identify a three-dimensional volume. For example, the region of interest may describe a tumor or a portion of a tumor to be treated.

In some implementations, a trajectory is determined for reaching the target region of interest (616). For example, the software may identify an access path leading from the probe introduction equipment (as identified by via the fiducial markers) to the region of interest. The access path, in some implementations, depends upon features of the brain discerned to be within a general path leading from the probe introduction equipment to the target region of interest. The features avoided by the software, for example, may include the brain stem, particularly fibrous tissues or major arteries. To identify the features of the brain to avoid, in some implementations, the software analyzes MRI images of the patient to identify known delicate and/or difficult to traverse features. In other implementations, a user may highlight within scanned images of the patient's brain one or more features to avoid when selecting a trajectory.

In some implementations, the software identifies two or more potential access paths and selects between the access paths. For example, depending upon particularly delicate or difficult to maneuver features of the brain between the region of interest and the position of the probe introduction equipment, the software may select between two or more possible access paths to identify the path least likely to cause difficulties during the procedure. The two or more possible access paths, in one example, include a path to one end of a target volume versus a path to another end of a target volume. In another example, the two or more possible access paths include two or more curved access paths to a single target point. The curved access path, for example, may be determined based upon identification of therapeutic instruments that will be used during the procedure. For example, a user may identify a particular probe or other equipment capable of curved trajectory towards a region of interest. A pre-shaped probe, for example, may be designed to deploy from the probe introduction equipment 210 (e.g., a guide sheath or guide stem) at a particular angle of curvature. The software, for example, upon receiving identification of the probe being used, may access data regarding the angle of curvature of the selected probe. In another example, the software algorithm may recommend a deployment device (e.g., guide sheath, guide sleeve, etc.) including an offset distal opening at a particular angle to effect the desired curved trajectory of a flexible cannula or laser fiber. For example, as illustrated in FIG. SI, the off-axis delivery hole 558 may be used to deploy the flexible cannula or laser fiber at a particular angle.

In some implementations, a flexible cannula or laser fiber can be automatically directed along a trajectory. For example, a flexible cannula or laser fiber may be capable of curved guidance using magnetic steering. In this example, one or more gradient coils may be used to guide the flexible cannula or laser fiber along a curved path to access a region of interest. In this example, the software may access capabilities of the magnetic steering system and flexible cannula or fiber to determine potential trajectory paths. Determining the trajectory, further to this example, may include determining commands to provide to a magnetic steering system to guide the flexible cannula or laser fiber to the region of interest.

In a further example, a robotic steering device such as a robotic worm may be used to pull a flexible neurosurgical instrument towards the region of interest along the curved access path. For example, the robotic worm may be remotely controlled to navigate a path towards a difficult to access region of interest while pulling or otherwise feeding the flexible neurosurgical device into position. In another example, the robotic worm may be programmed to follow a predetermined path to the region of interest such that, upon deployment (e.g., via a guide sheath or rigid cannula), the robotic worm steers the flexible neurosurgical instrument into position at the region of interest. The robotic worm, in some implementations, is further designed to create a path, for example through fibrous tissue, by cutting or bluntly pushing aside tissue to provide access for the flexible neurosurgical instrument. In some implementations, determining the trajectory includes determining commands to provide to the robotic worm to guide the flexible neurosurgical instrument to the region of interest.

In some implementations, one or more recommended adjustments for setting a trajectory of the probe introduction equipment are determined based upon the location of the region of interest and the initial position and orientation of the probe introduction equipment (618). In some implementations, the software identifies one or more adjustment features and/or ranges of motion of the particular type of probe introduction equipment. For example, using the guide stem 506 described in relation to FIG. 5C, the software may identify that the guide stem 506 has an infinitely adjustable trajectory via the ball joint, and based upon present orientation, to achieve the desired trajectory, a user may wish to align the guide stem 506 with particular guide lines. Similarly, based upon identification of the removable guide stem 520 having both the tilt adjustment 522 and the rotation adjustment 524, the software algorithm may identify two separate adjustments for setting the desired trajectory, both the tilt adjustment and the rotation adjustment (e.g., as identified by guide lines or other adjustment markers (or “clicks”) of the tilt adjustment 522 and/or the rotation adjustment 524).

If the probe introduction equipment includes an x,y degree of freedom adjustment mechanism for adjusting the position of the central cylindrical portion of guide stem in relation to the low profile skull anchoring device, the software may identify adjustment ranges of the x-y degree of freedom adjustment mechanism and recommend a modified offset of the guide stem to align with an optimal trajectory for reaching the region of interest.

In some implementations, the one or more recommended adjustments are provided for review by a medical professional (620). For example, the adjustments may be presented upon a display in communication with the workstation 106. In another example, the adjustments may be presented upon the display region of the interface platform 102 (as illustrated in FIG. 2) such that a user may review the instructions while setting the trajectory of the probe introduction equipment. In some implementations, in addition to the recommended adjustments, a displaced positioning of the representation of the probe introduction equipment may be overlaid on the displayed MRI image (e.g., illustrating the recommended alignment of the adjusted probe introduction equipment with the region of interest).

Using the recommended adjustments, for example, the medical professional may manually adjust the probe introduction equipment to the new trajectory. In other implementations, the probe driver 208 (illustrated in FIG. 3) and/or other automated equipment may be used instead or in coordination with manual adjustments to align the trajectory of the probe adjustment equipment. For example, the software may issue commands to the probe driver 208 to adjust a trajectory of the guide stem after receiving confirmation from a user that the guide stem locking mechanism is in an unlocked position. Upon positioning, the software may prompt the user to engage the locking mechanism, locking the guide stem into position.

After adjusting the trajectory, in some implementations, the user may request confirmation of desired trajectory via the software. To confirm the trajectory setting, for example, the software may compare present fiducial marker alignment with anticipated fiducial marker alignment (e.g., based upon change in position of the fiducial markers). In another example, the software may re-calculate a trajectory using the present fiducial markers and verify that the new trajectory aligns with the region of interest. The software, in a third example, may calculate an anticipated trajectory based upon the identified alignment (e.g., based upon a present position of the fiducial markers) and compare the anticipated trajectory to the trajectory calculated in step 616. Should the adjustment be misaligned for some reason, at least steps 616 and 618 of the method 600 may repeated as necessary.

D. Guide Sheath

Turning to FIGS. 5F and 5G, in certain embodiments, rather than inserting instruments directly into the removable guide stem 506 or 520, a guide sheath 540 is inserted into the removable guide stem (e.g., removable guide stem 506). The guide sheath 540 may include, for example, one or more distal openings and one or more proximal openings to introduce at least one neurosurgical instrument to the ROI in the patient's brain.

In certain embodiments, instead of using the guide sheath 540 configured for receipt of neurosurgical devices, a hollow trocar may be introduced via the removable guide stem 506 or 520 to prepare an initial entry into a region of the brain. For example, when entering a particularly fibrous area, rather than pushing in directly with a neurosurgical instrument and risking damage to the neurosurgical instrument, a trocar or stylette, may be used to cut a path for the neurosurgical instrument. The stylette or trocar, for example, may have a sharp distal opening to cut a path through the fibrous area. In another example, the trocar or stylette may have a bullet shaped nose to bluntly push tissue out of the trajectory path. In other implementations, a stylette or trocar may be introduced to the region of interest via the guide sheath 540.

In certain embodiments, the guide sheath 540 locks to the removable guide stem 506. The guide sheath 540, for example, may be configured to lock to the removable guide stem 506 at a variable linear height depending upon a distance between the skull opening and a ROI. In this manner, the guide sheath 540 may be deployed in proximity to, in the vicinity of, or adjacent to an ROI without abutting or entering the ROI. As such, upon removal of one or more neurosurgical instruments via the guide sheath 540, cells from the ROI will not be able to contaminate other regions of the patient's brain. In some implementations, a “wiper” mechanism designed into the distal end of the guide sheath 540 may aid in avoiding contaminants within the guide sheath 540.

Turning back to FIG. 5C, in certain embodiments, a guide stem locking mechanism 519 may be used to clamp the guide sheath 540 at a particular linear depth. The guide sheath 540, in a particular example, may have spaced indentations or other connection points for interfacing with the guide stem locking mechanism 519 (e.g., set screw or spring-loaded plunger). In other embodiment, the guide sheath may have spaced ratcheting teeth for interfacing with a ball plunger or toggle release. The indentations (or, alternatively, ratcheting teeth) may be positioned at precise measurements (e.g., 1 mm apart) to aid in linear position adjustment. In other examples, the guide sheath 540 and guide stem locking mechanism 519 may be configured to provide positive feedback to a medical professional during adjustment. For example, a linear actuator system such as a rack and pinion may be used to provide precise linear position adjustment (e.g., one “click” per millimeter). Upon adjustment, to lock the guide sheath 540 at the selected linear position, in certain embodiments a cam lock mechanism may be used to engage teeth or depressions within the guide sheath 540. For example, a cam lock mechanism such as the locking mechanism 516 illustrated in FIG. 5C may be used to lock the guide sheath 540 at a selected linear depth.

Turning back to FIG. 5D, the removable guide stem 520 similarly includes a guide stem locking mechanism 534. In other implementations, the guide sheath 540 may directly connect to the low profile skull anchoring device 504 or to another receiving port connected to the low profile skull anchoring device 504 (not illustrated).

The guide sheath 540, upon interlocking with the guide stem 506, 520 and/or the low profile skull anchoring device 504 and receiving one or more neurosurgical tools, may create an air-tight seal during a neurosurgical operation. For example, the proximal and/or distal end of the guide sheath 540 may include a receiving port adaptable to the surgical instrument being introduced. For example, the proximal and/or distal end of the guide sheath 540 may include an adjustable aperture that may be dialed or electronically set to a particular diameter matching a present neurosurgical instrument. In certain embodiments, various guide sheaths can be used interchangeably with the guide stem 506, 520, such that a guide sheath corresponding to the surgical instrument diameter may be selected. In other implementations, one or more guide sleeves (not illustrated) may be secured inside the guide sheath 540, each of the one or more guide sleeves having a different distal end diameter. A divided (e.g., bifurcated) guide sleeve, in certain embodiments, may be used to introduce two or more instruments simultaneously or concurrently, each with a particular instrument diameter.

In certain embodiments, the guide sheath 540 is intracranially delivered using an introducer and guide wire. An image guidance system, such as the MRI imaging system, may be used instead of or in addition to the introducer and guide wire during placement of the guide sheath 540. The guide sheath 540 may be composed of MRI compatible materials.

The materials of the guide sheath 540, in certain embodiments, are selected to provide rigid or inflexible support during introduction of one or more neurosurgical tools within the guide sheath 540. For example, the guide sheath 540 may be composed of one or more of Kevlar, carbon fiber, ceramic, polymer-based materials, or other MRI-compatible materials. The geometry of the guide sheath 540, in certain embodiments, further enhances the strength and rigidity of the guide sheath 540.

In certain embodiments, the guide sheath 540 (or guide sleeve, as described above) includes two or more lumens for introduction of various neurosurgical instruments. By introducing two or more neurosurgical instruments via the guide sheath 540, a series of treatments may be performed without interruption of the meninges layer between treatments. For example, FIG. SI illustrates two neurosurgical instruments 552 and 554 that are simultaneously inserted into a guide sheath 550 and can be used to carry out treatment of a tissue consecutively, concurrently, or simultaneously.

Neurosurgical instruments deployed via the guide sheath 540 may exit a same distal opening or different distal openings. In certain embodiments, the guide sheath 540 may include at least one off-axis distal opening. For example, as illustrated in FIG. 5H, exemplary guide sheath 550 includes a contact surface 556 having a predefined angle. Upon encountering the contact surface 556, the trajectory of a surgical instrument 552 presented through the guide sheath 550 may be deflected to exit the proximal end via an off-axis delivery hole 558, as illustrated in FIG. SI. The angles shown in FIGS. 5H and 5I can be considered as drawn to scale in one implementation. However, the alignment of the contact surface 556 and the delivery hole 558 can be varied by adjusting their respective axial angles. By adjusting these angles, a number of possible positions of the surgical instrument 554 are provided. Further, multiple off-axis delivery holes and multiple contact surfaces can be provided, which are displaced from each other in a direction of the longitudinal axis of the guide sheath.

Upon introducing a neurosurgical instrument such as a probe, in certain embodiments, the guide sheath 540 enables coupling between the probe and a probe actuation and guidance device. For example, commands for linear and/or rotational control of the probe may be issued to the probe via an interface within the guide sheath 540.

III. Probe

A number of different probes can be utilized in accordance with the various aspects presented in this disclosure. Example probes are described in: U.S. Pat. No. 8,256,430 to Torchia, entitled “Hyperthermia Treatment and Probe Therefor” and filed Dec. 17, 2007; U.S. Pat. No. 7,691,100 to Torchia, entitled “Hyperthermia Treatment and Probe Therefor” and filed Aug. 25, 2006; U.S. Pat. No. 7,344,529 to Torchia, entitled “Hyperthermia Treatment and Probe Therefor” and filed Nov. 5, 2003; U.S. Pat. No. 7,167,741 to Torchia, entitled “Hyperthermia Treatment and Probe Therefor” and filed Dec. 14, 2001; PCT/CA01/00905, entitled “MRI Guided Hyperthermia Surgery” and filed Jun. 15, 2001, published as WO 2001/095821; and U.S. patent application Ser. No. 13/838,310, entitled “Image-Guided Therapy of a Tissue” and filed Mar. 15, 2013. These documents are incorporated herein by reference in their entireties.

A number of probe lengths are provided in any of the probe examples described herein based on a degree of longitudinal travel allowed by a follower and a depth of the tissue to be treated. An appropriate probe length can be determined by the interface platform and/or the workstation during a planning stage, or determined during a trajectory planning stage.

Exemplary probe lengths can be indicated on the probes with reference to a probe shaft color, in which white can indicate “extra short” having a ruler reading of 113 mm, yellow can indicate “short” having a ruler reading of 134 mm, green can indicate “medium” having a ruler reading of 155 mm, blue can indicate “long” having a ruler reading of 176 mm, and dark gray can indicate “extra long” having a ruler reading of 197 mm. Different model numberings can also be utilized on the probes to indicate different lengths.

In general, a therapeutic window of wavelengths for thermal therapy using a laser probe ranges from 800 to 1100 nm. Wavelengths lower than 800 (e.g., within the visible spectrum) lack the energy to effectively heat tissue, while wavelengths above 1100 nm rapidly heat an immediate region, thereby being useful in applications such as tattoo removal where a thin region is burned. In some implementations, a laser probe has a 1064 nm wavelength for coagulation of tissue. The 1064 nm wavelength, for example, is selected based upon water absorption properties of laser wavelengths. By minimizing water absorption, for example, depth of penetration can be maximized. The 1064 nm laser probe, for example, may be used to apply thermal therapy to a three-dimensional zone approximately two to four centimeters in diameter. Thus, the 1064 nm wavelength allows deeper penetration and provides a higher power density associated with energy application so as to more efficiently effect thermal therapy. In certain embodiments, the laser probe is cooled via Joule-Thompson cooling, which eliminates and/or minimizes energy absorption and scatter, as discussed in further detail below.

In some implementations, the laser probe is a side-firing laser probe to focus the energy of the 1064 nm wavelength laser. For example, beyond the penetration zone of the laser probe (e.g., about two to four centimeters), the photon scattering can cause difficulties in focusing the therapy. Depth of penetration may be improved through focusing a laser beam using a side-firing design. Similar benefits may be achieved in designing a side-firing HIFU probe, as described below.

An energy output pattern of a probe, such as a laser probe or HIFU probe, in certain embodiments, includes a pulsed output pattern. For example, a higher power density may be achieved without causing tissue scorching by pulsing a high power laser treatment for x seconds with y seconds break between (e.g., allowing for tissue in the immediate vicinity to cool down). Furthermore, pulsing allows the system to vary energy delivered to a region of interest without affecting the power density applied to the region of interest. In this manner, higher energy can be applied to a region of interest without causing damage (e.g., scorching) to immediate tissue. In a particular example, the energy output pattern of a probe may include a ten Watt output for 2 to 2.5 seconds followed by a one to 1.5 second period of inactivity (e.g., delivering approximately 398 Joules per minute). In certain embodiments, a particular energy output pattern may be developed based upon the type of probe (e.g., laser, HIFU, etc.), an emission style of the probe tip (e.g., side-firing, diffuse tip, etc.), and/or the depth of the ROI and/or the targeted tissue area (e.g., based in part on the shape of a tumor region, etc.). For example, in a diffuse tip design, the energy output pattern for the diffuse tip probe may include a ten Watt output for 2 seconds, followed by a 0.3 second period of inactivity (e.g., delivering approximately 500 Joules per minute).

In some implementations, based upon feedback received through thermal imaging, the energy output pattern may be adjusted. For example, the period of inactivity may be lengthened or shortened depending upon a temperature gradient between the tissue closest to the probe and the depth of treatment (e.g., the furthest tissue being thermally ablated). In another example, the power output of the probe may be adjusted instead of or in addition to the period of inactivity, based upon thermal imaging feedback. For example, to increase a treatment radius, the power density supplied by the probe may be increased.

In some implementations, to further guard against tissue scorching, the laser probe may include a cooling tip to cool tissue within the immediate vicinity. During the period of inactivity between pulses, for example, the tip of the laser probe may cool to approximately 0 to 5 degrees Celsius. A cryogenic cooling device (e.g., cooling tube) may be designed into a 1064 nm wavelength side-firing laser probe, in a particular example, to affect cooling to surrounding tissue during inactive periods between energy pulses. A thermocouple within the cooling device, further to the example, can be read during inactive periods to avoid interference caused by energy emission. The 1064 nm wavelength allows deeper penetration and higher power density; that is, thermal therapy can cause cellular damage to a targeted tissue region in a shorter period of time.

In certain embodiments, a treatment pattern includes effecting treatment while concurrently or simultaneously moving the probe (e.g., linearly and/or rotationally). For example, a HIFU probe may be automatically rotated (e.g., using a commander and follower as described in FIG. 3, etc.) while an emission pattern is simultaneously or concurrently adjusted to effect treatment to a desired depth based upon a particular geometry of the ROI. In this manner, for example, while the ultrasonic probe's beam is focused on a radial portion of the tumor having a depth of 1.5 centimeters, the power density of the HIFU probe may be tuned for the first treatment depth. Upon rotation, a second radial portion of the tumor may have a depth of 2 centimeters, and the power density of the HIFU probe may be increased accordingly to tune for the treatment depth of 2 centimeters. If two or more ultrasonic transducers are included in the HIFU probe, the power may be varied on a per-transducer basis or to the entire transducer array.

A. Side-Fire HIFU Probe

Turning to FIG. 7A, a view 700 of an exemplary treatment scenario involving a HIFU probe 702 deployed to treat an ROI 706 is illustrated. HIFU technology advantageously provides directional control and greater depth penetration as compared with laser-based thermal therapy. For example, in comparison to laser therapy, ultrasonic therapy may achieve at least three to four times greater depth penetration. For example, estimated depths of thermal treatment using HIFU technology include three to five centimeters or greater than six centimeters. By completing treatment via an initial trajectory, the treatment may be performed faster and less invasively than it may have been performed using a laser probe. As such, a HIFU probe may be used to treat a larger ROI without the need to adjust a probe trajectory or introduce the probe into multiple locations within the brain. Although treatment may be provided at a greater depth, it also may be provided using a narrow focal beam, containing a width of the treated tissue. Furthermore, although HIFU-based thermal therapy can advantageously achieve a greater penetration depth than laser-based thermal therapy, the ultrasonic treatment has greater uniformity over temperature gradients than laser-based thermal therapy, which heats a portion of the targeted tissue area close to the probe much more rapidly than portions of the targeted tissue area further away from the probe. In selecting thermal therapy via a HIFU probe, scorching or carbonization of the targeted tissue area close to the probe may be avoided and/or the HIFU probe may be operated independently of external cooling to protect immediately surrounding tissue.

In performing thermal therapy using a HIFU probe, constructive and destructive interference can be utilized by selecting a number of different longitudinal spaced emission points to fine tune a position and depth of energy applied to a targeted tissue area and/or an ROI. As such, the depth of energy, as such, may be tuned to conform with a non-uniform, irregular, and/or non-polygonal shape of the ROI which, for example, corresponds to a tumor. For example, power supplied to the transducers of a side firing HIFU probe may be varied as the HIFU probe is rotated to a new position, thereby adjusting penetration of the ultrasonic energy to a depth of the a region of interest (e.g., tumor) at the present angle of rotation. In this manner, HIFU treatment may be used to “sculpt” an irregularly shaped three-dimensional lesion conforming to a region of interest through power variance during rotation of the probe. As noted above, because HIFU treatment may reach a penetration depth of three to five centimeters or even greater than six centimeters, it is imaginable that an irregularly-shaped tumor of at least 5 centimeters in diameter may be treated without the need to adjust an initial trajectory of the HIFU probe. In certain embodiments, the side-fire HIFU probe may treat an ROI having a tumor volume of up to 110 cubic centimeters. In other embodiments, the side-fire HIFU probe may treat an ROI having a tumor volume with a range of approximately 0.1 cubic centimeters and 110 cubic centimeters. Preparing trajectories, determining linear translational adjustments and/or rotational movements, and/or energy output patterns may be selected and/or optimized to prevent heating of the skull and/or bouncing energy off of the surfaces of the skull. HIFU treatment, in some examples, can be used for opening a blood-brain barrier, coagulation of tissue, or cavitation of tissue.

The HIFU probe 702 includes one or more side-firing transducers 704 for effecting treatment to the ROI 706. The ultrasonic transducer(s) 704 may be flat or rounded. The HIFU probe, in some examples, can include a shaft composed of plastic, brass, titanium, ceramic, polymer-based materials, or other MRI-compatible materials in which one or more ultrasonic transducer(s) 704 have been mounted. The ultrasonic transducer(s) 704 may be mounted upon an interior surface of the shaft of the HIFU probe 702. The ultrasonic transducer(s) 704 may include a linear array of individually controllable transducers, such that a frequency or power output of each transducer 704 may be individually tuned to control a treatment beam of the HIFU probe 702. For example, as illustrated in FIG. 7C, the tip of the probe 702 can include a linear array of three transducers 704. The longitudinally spaced apart transducers 704 can be spaced equally apart. However, in other implementations, the spacing between the transducers 704 can be unequal.

In certain embodiments, the HIFU probe 702 includes a cooling mechanism for cooling the ultrasonic transducers 704. For example, a cooling fluid or gas may be delivered to the tip of the HIFU probe 702 to control a temperature of the ultrasonic transducer(s) 704. Additionally, the ultrasonic transducer(s) 704 may be surrounded by an acoustic medium, such as an acoustic coupling fluid (e.g., water) to enable ultrasonic frequency tuning of the ultrasonic transducer(s) 704.

As illustrated in FIG. 7A, the HIFU probe 702 is embedded within an ROI 706 spanning multiple MR thermal monitoring planes 708. During treatment, thermal effects within each MR thermal monitoring plane 708 may be monitored in order to monitor thermal coagulation of the ROI 706. Information derived from the thermal monitoring, for example, may be fed back into control algorithms of the HIFU probe 702, for example, to adjust a power intensity and/or frequency of the HIFU probe to tune a depth of treatment of the ultrasonic beam or to adjust a rotational and/or linear positioning of the HIFU probe 702 upon determining that ablation is achieved at a current rotational and linear position.

To increase the monitoring region, additional MR thermal monitoring planes 708 may be monitored (e.g., between four and eight planes, up to twelve planes, etc.). Alternatively, in certain embodiments, the three thermal monitoring planes 708 may be spread out over the y-axis such that a first gap exists between plane 708 a and plane 708 b and a second gap exists between plane 708 b and plane 708 c. The thermal monitoring algorithm, in this circumstance, can interpolate data between the MR thermal monitoring planes 708.

In other implementations, rather than obtaining parallel images of MR thermal monitoring planes, at least three thermal monitoring planes, each at a distinct imaging angle bisecting an axis defined by a neurosurgical instrument such as a thermal ablation probe, may be interpolated to obtain thermal data regarding a three-dimensional region.

Turning to FIG. 8A, an aspect illustration 800 demonstrates three MR thermal monitoring planes 802 for monitoring ablation of an ROI 804 by a probe 806. The angles between the thermal monitoring planes, in some examples, may be based upon an anatomy of the region of the skull of the patient or a shape of the ROI. The angles, in some examples, may differ by at least ten degrees.

Turning to FIG. 8B, an end view 810 of the probe 806 provides an illustrative example of MR thermal monitoring planes 802 that are each offset by sixty degrees. In comparison to using parallel MR thermal monitoring planes, the thermal monitoring planes 802 provide a more realistic three-dimensional space. Temperature gradients and/or thermal dose profiles between the thermal monitoring planes 802 can be interpolated. Similar to increasing a number of parallel MR thermal monitoring planes, in other implementations, four or more thermal monitoring planes may be captured and combined, for example, to increase thermal monitoring accuracy.

As a result of the side-firing capability of the HIFU probe 702, a number of rotationally different portions of the ROI can be treated with the ultrasonic energy by rotating the HIFU probe 702. For example, as illustrated in an x-axis sectional view 710, the HIFU probe 702 may be rotated is illustrated in an arrow 712 to effect treatment throughout the ROI 706. Additionally, the HIFU probe 702 can be longitudinally translated, for example automatically by a follower of a probe driver, to change a longitudinal position at which ultrasonic energy is applied within the ROI 706.

Rotation, power intensity, duty cycle, longitudinal positioning, and cooling, in certain embodiments, are controlled by the electronics rack 104 and the workstation 106, such as the electronics rack 104 and workstation 106 described in relation to FIG. 1. A sequence, such as an algorithm or software encoding, can be executed to cause a probe tip or a number of probe tips to execute a particular energy output pattern effect a predefined thermal therapy to a targeted tissue area. The energy output pattern can be based on rotational and/or longitudinal movements of the probe.

The procedures and routines described herein can be embodied as a system, method or computer program product, and can be executed via one or more dedicated circuits or programmed processors. Accordingly, the descriptions provided herein may take the form of exclusively hardware, exclusively software executed on hardware (including firmware, resident software, micro-code, etc.), or through a combination of dedicated hardware components and general processors that are configured by specific algorithms and process codes. Hardware components are referred to as a “circuit,” “module,” “unit,” “device,” or “system.” Executable code that is executed by hardware is embodied on a tangible memory device, such as a computer program product. Examples include CDs, DVDs, flash drives, hard disk units, ROMs, RAMs and other memory devices.

FIG. 9 illustrates an example processing system 900, and illustrates example hardware found in a controller or computing system (such as a personal computer, i.e., a laptop or desktop computer, which can embody a workstation according to this disclosure) for implementing and/or executing the processes, algorithms and/or methods described in this disclosure. The processing system 900 in accordance with this disclosure can be implemented in one or more the components shown in FIG. 1. One or more processing systems can be provided to collectively and/or cooperatively implement the processes and algorithms discussed herein.

As shown in FIG. 9, the processing system 900 in accordance with this disclosure can be implemented using a microprocessor 902 or its equivalent, such as a central processing unit (CPU) and/or at least one application specific processor ASP (not shown). The microprocessor 902 is a circuit that utilizes a computer readable storage medium 904, such as a memory circuit (e.g., ROM, EPROM, EEPROM, flash memory, static memory, DRAM, SDRAM, and their equivalents), configured to control the microprocessor 902 to perform and/or control the processes and systems of this disclosure. Other storage mediums can be controlled via a controller, such as a disk controller 906, which can controls a hard disk drive or optical disk drive.

The microprocessor 902 or aspects thereof, in alternate implementations, can include or exclusively include a logic device for augmenting or fully implementing this disclosure. Such a logic device includes, but is not limited to, an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), a generic-array of logic (GAL), and their equivalents. The microprocessor 902 can be a separate device or a single processing mechanism. Further, this disclosure can benefit from parallel processing capabilities of a multi-cored CPU.

In another aspect, results of processing in accordance with this disclosure can be displayed via a display controller 908 to a display device (e.g., monitor) 910. The display controller 908 preferably includes at least one graphic processing unit, which can be provided by a number of graphics processing cores, for improved computational efficiency. Additionally, an I/O (input/output) interface 912 is provided for inputting signals and/or data from microphones, speakers, cameras, a mouse, a keyboard, a touch-based display or pad interface, etc., which can be connected to the I/O interface as a peripheral 914. For example, a keyboard or a pointing device for controlling parameters of the various processes and algorithms of this disclosure can be connected to the I/O interface 912 to provide additional functionality and configuration options, or control display characteristics. An audio processor 922 may be used to process signals obtained from I/O devices such as a microphone, or to generate signals to I/O devices such as a speaker. Moreover, the display device 910 can be provided with a touch-sensitive interface for providing a command/instruction interface.

The above-noted components can be coupled to a network 916, such as the Internet or a local intranet, via a network interface 918 for the transmission or reception of data, including controllable parameters. A central BUS 920 is provided to connect the above hardware components together and provides at least one path for digital communication there between.

The workstation shown in FIG. 1 can be implemented using one or more processing systems in accordance with that shown in FIG. 9. For example, the workstation can provide control signals to peripheral devices attached to the I/O interface 912, such as actuators 924 to drive probe positioning and actuation equipment. The workstation, in some implementations, can communicate with additional computing systems, such as an imaging unit 926 and/or an MRI unit 928, via the I/O interface 912.

One or more processors can be utilized to implement any functions and/or algorithms described herein, unless explicitly stated otherwise. Also, the equipment rack and the interface platform each include hardware similar to that shown in FIG. 9, with appropriate changes to control specific hardware thereof.

Reference has been made to flowchart illustrations and block diagrams of methods, systems and computer program products according to implementations of this disclosure. Aspects thereof are implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computer-readable medium that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable medium produce an article of manufacture including instruction means which implement the function/act specified in the flowchart and/or block diagram block or blocks.

The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of this disclosure. For example, preferable results may be achieved if the steps of the disclosed techniques were performed in a different sequence, if components in the disclosed systems were combined in a different manner, or if the components were replaced or supplemented by other components. The functions, processes and algorithms described herein may be performed in hardware or software executed by hardware, including computer processors and/or programmable circuits configured to execute program code and/or computer instructions to execute the functions, processes and algorithms described herein. Additionally, some implementations may be performed on modules or hardware not identical to those described. Accordingly, other implementations are within the scope that may be claimed. 

1. A method for effecting thermal therapy using an in vivo probe, comprising: positioning the probe in a volume in a patient; identifying a three-dimensional region of interest at which to apply thermal therapy, wherein the three-dimensional region of interest is irregularly shaped; and applying, by processing circuitry, thermal therapy to the volume using the probe, wherein applying thermal therapy comprises a) identifying a first emission level corresponding to thermal therapy of the three-dimensional region of interest at a first rotational angle of the probe, wherein the first emission level is based at least in part upon a depth of a radial portion of the region of interest in the direction of probe emission at the first rotational angle, b) activating emission of the probe to deliver therapeutic energy at the first emission level to the three-dimensional region of interest at the first rotational angle, c) causing rotation of the probe to a next rotational angle, d) identifying a next emission level corresponding to thermal therapy of the three-dimensional region of interest at the next rotational angle of the probe, wherein the next emission level is based at least in part upon a depth of a radial portion of the region of interest in the direction of probe emission at the next rotational angle, e) activating emission of the probe to deliver therapeutic energy at the next emission level to the three-dimensional region of interest at the next rotational angle, and f) repeating steps (c) through (e) until therapeutic energy has been delivered to at least a first volume of the three-dimensional region of interest.
 2. The method of claim 1, further comprising: i) activating linear adjustment of the probe to move to a next volume of the three-dimensional region of interest; ii) initiating additional thermal therapy, wherein the additional thermal therapy comprises performing steps (a) through (f); and iii) repeating steps (i) and (ii) until therapeutic energy has been delivered to the entire volume of the three-dimensional region of interest.
 3. The method of claim 1, wherein applying thermal therapy comprises continuously monitoring, throughout repetition of steps (c) through (e), respective tissue temperatures at a respective rotational angle corresponding to emission within the first volume of the three-dimensional region of interest.
 4. The method of claim 3, wherein monitoring the respective tissue temperatures comprises performing thermographic analysis of magnetic resonance (MR) images.
 5. The method of claim 1, wherein applying thermal therapy further comprises: while delivering therapeutic energy at the first emission level, monitoring respective temperatures of a plurality of points, wherein each point of the plurality of points is a) within the three-dimensional region of interest or b) adjacent to the three-dimensional region of interest; and prior to rotating the probe to the next rotational angle, determining, based on at least one of the respective temperatures of the plurality of points and a thermal dose that is based on a temperature history of the plurality of points over a specified time period, to conclude delivery of therapeutic energy at the first rotational angle.
 6. The method of claim 5, wherein performing thermographic analysis comprises analyzing MR images corresponding to each of a plurality of thermal monitoring planes, wherein a first portion of the plurality of points is within a first thermal monitoring plane of the plurality of thermal monitoring planes, and a second portion of the plurality of points is within a second thermal monitoring plane of the plurality of thermal monitoring planes.
 7. The method of claim 6, wherein: each thermal monitoring plane of the plurality of thermal monitoring planes is separated from all adjacent thermal monitoring planes of the plurality of thermal monitoring planes by a respective gap; and applying thermal therapy comprises, prior to determining to conclude delivery of therapeutic energy at the first rotational angle, interpolating temperature data for regions within the gaps between adjacent thermal monitoring planes.
 8. The method of claim 6, wherein each thermal monitoring plane of the plurality of thermal monitoring planes intersects the other thermal monitoring planes by a respective angle, wherein the respective angle is determined based at least in part upon one of a) a geometry of the region of interest, and b) a geometry of a region of a skull of the patient.
 9. The method of claim 5, wherein monitoring the respective temperatures of the plurality of points comprises indicating, based at least in part upon at least one of the respective temperatures of the plurality of points and the thermal dose, cellular death of tissue at the first angle of rotation.
 10. A system for effecting in vivo thermal therapy comprising: a probe; a probe driver connected to the probe and operable to manipulate at least an angle of rotation of the probe; a processor; and a memory having instructions stored thereon, wherein the instructions, when executed by the processor, cause the processor to, while the probe is positioned within in a volume in a patient: a) identify a first emission level at which to deliver therapeutic energy to a three-dimensional region of interest at a first rotational angle of the probe, b) activate delivery of therapeutic energy at the first emission level to the three-dimensional region of interest at the first rotational angle, c) identify, based at least in part upon monitoring respective temperatures of a first plurality of points, completion of thermal therapy at the first rotational angle, wherein each point of the first plurality of points is within the three-dimensional region of interest or adjacent to the three-dimensional region of interest, d) direct the probe driver to rotate the probe to a next rotational angle, e) identify a next emission level at which to deliver therapeutic energy to the three-dimensional region of interest at the next rotational angle of the probe, f) activate delivery of therapeutic energy at the next emission level to the three-dimensional region of interest at the next rotational angle, g) identify, based at least in part upon monitoring temperatures of a next plurality of points, completion of treatment at the next rotational angle, wherein each point of the second plurality of points is within the three-dimensional region of interest or adjacent to the three-dimensional region of interest, and h) repeat steps (d) through (g) until therapeutic energy has been delivered to at least a first volume of the three-dimensional region of interest.
 11. The system of claim 10, wherein the therapeutic energy is ultrasonic energy; and the probe is a high intensity focused ultrasound (HIFU) probe operable to effect cellular damage within the three-dimensional region of interest at a depth of at least one centimeter.
 12. The system of claim 11, wherein the HIFU probe comprises at least one ultrasound producing element mounted in a side-firing position within a rigid external shaft.
 13. The system of claim 11, wherein the cellular damage comprises reversible cellular damage.
 14. The system of claim 10, wherein: the therapeutic energy is laser energy; and the probe is a side-firing probe.
 15. The system of claim 10, wherein the second plurality of points comprises at least a portion of the first plurality of points.
 16. The system of claim 10, further comprising a workstation located in a control room separate from a room containing the probe and probe driver, wherein the workstation comprises the processor.
 17. The system of claim 16, wherein: thermal therapy is initiated via user input to the workstation; and the instructions further cause the processor to present, upon a display device, at least one thermal monitoring view pane illustrating the region of interest.
 18. A non-transitory computer readable medium having instructions stored thereon, wherein the instructions, when executed by a processor, cause the processor to effect thermal therapy to a three-dimensional region of interest within a volume of a patient, the thermal therapy comprising: a) identifying a first dose profile for effecting thermal therapy, wherein the first dose profile includes one or more of a time period, and a geometry of a first target area of the three-dimensional region of interest; b) identifying, based at least in part on the first dose profile, a first emission level at which to deliver therapeutic energy to the three-dimensional region of interest at a first rotational angle of a probe; c) activating delivery of therapeutic energy by the probe at the first emission level to the three-dimensional region of interest at the first rotational angle; d) monitoring feedback related to the first target area, wherein the feedback comprises at least one of temperature feedback and imaging feedback; e) determining, based at least in part on the feedback, completion of thermal therapy at the first rotation angle; f) activating rotation of the probe to a next rotational angle; g) identifying, based at least in part on a next dose profile, a next emission level at which to deliver therapeutic energy to the three-dimensional region of interest at the next rotational angle of the probe; h) activating delivery of therapeutic energy by the probe at the next emission level to the three-dimensional region of interest at the next rotational angle; i) monitoring feedback related to the next target area to determine completion of thermal therapy at the next rotation angle; and j) repeating steps (f) through (i) until therapeutic energy has been delivered to at least a first volume of the three-dimensional region of interest.
 19. The computer readable medium of claim 18, wherein the first emission level comprises a first power level corresponding to a depth of the three-dimensional region of interest at the first rotational angle, wherein the depth is identified by the geometry of the first target area.
 20. The computer readable medium of claim 18, wherein rotating the probe comprises rotating the probe while continuing to deliver therapeutic energy, such that therapeutic energy is constantly delivered during thermal therapy of the three-dimensional region of interest.
 21. The computer readable medium of claim 18, wherein the instructions, when executed, further cause the processor to, after delivering therapeutic energy to the first volume of the three-dimensional region of interest: activate linear adjustment of the probe; and initiate a second thermal therapy.
 22. The computer readable medium of claim 21, wherein the instructions, when executed, further cause the processor to, prior to initiating the second thermal therapy, verify a current placement of the probe.
 23. The computer readable medium of claim 22, wherein verifying the current placement of the probe comprises: identifying, within imaging data, a plurality of fiducial markers; and calculating a probe position based at least in part upon identification of the plurality of fiducial markers. 